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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023909
Receipt No. R000027492
Scientific Title Six-month Kohzuki Exercise Program improves physical function in frail older people in multifunctional long-term care in a small group home: a randomized controlled pilot trial
Date of disclosure of the study information 2016/09/16
Last modified on 2018/09/14

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Basic information
Public title Six-month Kohzuki Exercise Program improves physical function in frail older people in multifunctional long-term care in a small group home: a randomized controlled pilot trial
Acronym The effect of physical exercise for frail older people
Scientific Title Six-month Kohzuki Exercise Program improves physical function in frail older people in multifunctional long-term care in a small group home: a randomized controlled pilot trial
Scientific Title:Acronym The effect of physical exercise for frail older people
Region
Japan

Condition
Condition The eligibility criteria for inclusion were (i) 65 years or older; (ii) frail (meeting the specified cut-off for three or more of the CHS frailty criteria: slow gait, weak grip, exhaustion, low energy expenditure, and weight loss) [4]; (iii) Mini-Mental State Examination [19] score >21; and (iv) absence of participation in aerobic exercise and strength training.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the aim of this study was to determine the effect of a 6-month structured KEP on physical function in frail older people in MSGH. The hypothesis was that the KEP would improve physical function in frail older people.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Short Physical Performance Battery(SPPB)
Key secondary outcomes Barthel Index(BI)
Medical Outcomes Study 12-item Short Form Health Survey Instrument(SF-12)
Geriatric Depression Scale-Short Form 15(GDS)
Pittsburgh Sleep Quality Index(PSQI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The Exercise Group participants engaged in the KEP 3 times a week for 6 months, totaling 72 sessions. All sessions began with 5 minutes of warm-up and stretching, followed by 30 minutes of lower-limb aerobic exercise using a Terasuerugo (Showadenki Co., Ltd., Osaka, Japan), and 5 minutes of cool-down and relaxation (72 sessions in all).
Interventions/Control_2 CG participants were asked to maintain their normal behavior over the same 6-month period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria The eligibility criteria for inclusion were (i) 65 years or older; (ii) frail (meeting the specified cut-off for three or more of the CHS frailty criteria: slow gait, weak grip, exhaustion, low energy expenditure, and weight loss) [4]; (iii) Mini-Mental State Examination [19] score >21; and (iv) absence of participation in aerobic exercise and strength training.
Key exclusion criteria The exclusion criteria for the participants were (i) any acute cardiorespiratory episode within 1 year before the study; (ii) neurological or neuromuscular disease that could interfere with the proper performance of assessment and/or exercise protocol; and (iii) dementia or psychiatric disorders.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Kohzuki
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal Medicine & Rehabilitation Science
Zip code
Address 1-1, Seiryo street, Aoba ward, Sendai city
TEL 022-717-7351
Email kohzuki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chaewon Lee
Organization Tohoku University Graduate School of Medicine
Division name Department of Internal Medicine & Rehabilitation Science
Zip code
Address 1-1, Seiryo street, Aoba ward, Sendai city
TEL 022-717-7353
Homepage URL
Email terramoris@dc.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学大学院(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027492

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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